Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.

• ClinicalTrials.gov Identifier: NCT00401830
• Recruitment Status: Completed
• First Posted: November 22, 2006
• Results First Posted: October 22, 2009
• Last Update Posted: July 18, 2018
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

Brief Summary:

This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia Syndrome	Drug: Lacosamide; Other: Placebo	Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Detailed Description:

This was a proof-of-concept study and not powered for statistical comparisons.

The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 159 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400 mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
• Study Start Date: October 2006
• Actual Primary Completion Date: February 2008
• Actual Study Completion Date: February 2008

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo	Other: Placebo; Matching placebo tablet administered twice daily
Experimental: Lacosamide; Lacosamide Tablet 400mg daily	Drug: Lacosamide; Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg; Other Names: Vimpat; Harkoseride

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set) [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]
   The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
2. Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set) [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]
   The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

Secondary Outcome Measures :

1. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
   The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia
2. Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
   Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.
3. Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]
   Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)
4. Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]
   General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)
5. Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ]
   An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
6. Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ]
   An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
7. Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
   The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).
8. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
   The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.
9. Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ]
   Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.
10. Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ]
    Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).
11. Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
    All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.
12. Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 [ Time Frame: End of the Maintenance Phase/Week 12 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Males or females, 18 to 65 years old
• Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia
• At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7 days prior to Baseline)
• Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50
• Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase

Exclusion Criteria:

• Symptomatic regional or structural rheumatic disease
• Diagnosed neuropathic pain syndrome
• Receiving treatment with neurostimulating devices
• Significant psychopathology
• History of chronic alcohol or drug abuse within 6 months prior to Screening
• Been hospitalized for psychiatric or behavioral reasons within 6 months prior to Screening
• Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias
• Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs)
• Other medical conditions that could compromise the subject's ability to participate in the study

Contacts and Locations

Locations

United States, Arizona

Litchfield Park, Arizona, United States

United States, California

Santa Ana, California, United States, 92705

Walnut Creek, California, United States, 94598

United States, Florida

Deerfield Beach, Florida, United States, 33064

Fort Lauderdale, Florida, United States, 33334

Fort Myers, Florida, United States, 33916

Tampa, Florida, United States, 33614

United States, Georgia

Athens, Georgia, United States

Decatur, Georgia, United States, 30033

United States, Illinois

Peoria, Illinois, United States, 61614

United States, Indiana

Evansville, Indiana, United States, 47714

United States, Kentucky

Madisonville, Kentucky, United States, 42431

United States, Maryland

Columbia, Maryland, United States, 21045

Frederick, Maryland, United States, 21702

United States, Massachusetts

Brockton, Massachusetts, United States, 20301

United States, North Carolina

Charlotte, North Carolina, United States, 28210

Winston-Salem, North Carolina, United States, 27103

United States, Ohio

Mogadore, Ohio, United States, 44260

Toledo, Ohio, United States, 43623

United States, South Carolina

Goose Creek, South Carolina, United States, 29445

United States, Tennessee

Memphis, Tennessee, United States, 30033

United States, Texas

San Antonio, Texas, United States, 78213

San Antonio, Texas, United States

United States, Virginia

Richmond, Virginia, United States, 23294

United States, Washington

Kirkland, Washington, United States, 98033

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls 

Product Information 

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00401830
• Other Study ID Numbers: SP0887
• First Posted: November 22, 2006
• Results First Posted: October 22, 2009
• Last Update Posted: July 18, 2018
• Last Verified: July 2017

Keywords provided by UCB Pharma:

Fibromyalgia Syndrome; Lacosamide; Vimpat; Harkoseride

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Syndrome; Disease; Pathologic Processes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Lacosamide; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action